Associate MDR/Vigilance Specialist

Associate MDR/Vigilance Specialist (24-month contract // Mounds View, MN):

Manager Note: Onsite 4 days/week, remote 1 day/week

HM's Top Needs:

1. Nursing/medical backgrounds (ideally with clinical experience working with medical devices)
2. Biomedical engineering or biomedical neuroscience backgrounds (education without on-the-job experience is sufficient)
3. Pre-med, pre-vet educations (essentially, any degree with a heavy focus on biological sciences including anatomy, physiology, etc.)

Education Required: Bachelor's Degree in Science

Years’ Experience Required: 0-2 years in quality, regulatory, post market surveillance, or medical professional would be ideal

Description:

In this exciting role as an Associate MDR/Vigilance Specialist, you will have the responsibility and authority to document and evaluate product feedback and product analysis results for the client’s products to determine complaint status and regulatory reporting status in conjunction with US and OUS regulatory guidelines. In conjunction with US and OUS regulatory reporting criteria, the Associate MDR/Vigilance Specialist compiles regulatory agency reports for submission. As part of complaint closure activities this individual performs activities to monitor complaint activity to ensure timely review of product feedback, product analysis, product formal investigation, and any associated follow-up actions that pertain to complaint closure.

Duties:

• Apply policies and procedures to comply with FDA and OUS regulations.
• Monitors the company's drug or medical devices surveillance program including the intake, protocol development, evaluation, processing, and follow-up on adverse event reports, complying with government regulations.
• Evaluate incoming information to determine Medical Device Reporting and Vigilance reporting eligibility.
• Ensures complete, accurate, and timely submission of Medical Device Reports (MDRs), Vigilance Reports (VR) Adverse Drug Experience (ADE) data or adverse reaction data as required by regulatory agencies.
• Interface and collaborate with internal and external contacts to ensure appropriate collection of complaint information in an efficient and customer focused manner.
• Maintain awareness of new products, government regulations, and requirements.
• Acts as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements.
• Monitors the company's drug or medical devices surveillance program including the intake, protocol development, evaluation, processing, and follow-up on adverse reports, participation in the resolution of any legal liability and in complying with government regulations.
• Ensures complete and accurate maintenance and reporting of Medical Device Reports (MDRs), Adverse Drug Experience (ADE) data or adverse reaction data as required by regulatory agencies.
• Review and analyze clinical databases for the extraction of ADE data and integrates the data to ensure the creation of a unified database consistent with the aims and purposes of ADE standardization and internalization as well as to ensure the accuracy and quality of safety summaries.
• Acts as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements.
• Other duties as assigned.

Must Have:

• Bachelor of science degree
• High level of computer proficiency (e.g. Microsoft Office, SAP, Siebel, Oracle Clinical, etc.)
• 0-2 years' experience in healthcare or medical device/pharmaceutical industry in safety or clinical data evaluation

Nice to Have:

• Degree in nursing, biology/pre-med or pre-vet, or biomedical engineering
• Medical device industry experience
• Strong verbal and written communication skills
• Knowledge of basic anatomy and physiology
• Strong attention to detail
• High level of computer proficiency